MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number	8015
Medical Device Problem Codes	Contamination (1120); Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual date of event is unknown.Bd technical support troubleshoot with customer over the phone.A device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.Investigation summary: the reported missing event logs issue was confirmed through the provided facility log file and is attributed to a log purge.A preventive maintenance task was performed on suspect device to verify its performance, and no issues or anomalies were found inspection identified significant corrosion and contamination of unknown fluid on the inner surface of the rear case.The suspect pcu event logs were received via email to ascertain programming details between 12 january 2026 to 22 january 2026.A review of the event logs provided by the facility showed that no activity was recorded between january 12 and january 15, 2026, which aligns with the regarding issue of missing logs.The first registered events begin on january 16, 2026, and continue through january 22, 2026.Error, event and battery logs were retrieved from the returned suspect pcu to ascertain programming and event details associated with the alleged incident.However, the downloaded logs started on 17 january 2026 at 4:26 am which indicates the incident dates from 12 january 2026 to 16 january 2026 have been overwritten due to continued use.Therefore, the event log review of 16 january 2026 was conducted with the returned facility logs, it is important to notice that due to the limitations of the received logs, some of the parameters could not be determined such as some drugs and channel labels, as most of the parameters were programmed prior the recorded dates.On 16 january 2026, at 4:41 am pcu activity begins with a pre programmed infusion initiated on pump module s/n 14384151 a few minutes after, at 4:59 am, a previous infusion on pump module s/n 13684574 was completed, right after the user programmed a new infusion, adjusting vtbi and starting the infusion again.Between 5:10 am and 6:18 am, several modules showed continuous infusion activity.On pump module s/n 13684574, the user changed the vtbi to 200 ml.On pump module s/n 14384151, the user modified the dose to 15 mcg, initiating a new infusion with updated parameters.Pump module s/n 14383848 continued infusing without parameter changes, while pump module s/n 14385616 operated under a newly programmed secondary infusion that started and continued infusing as intended.On january 17, 2026, from 1:05 am to 10:15 am, pump modules 13684574, 14384151, and 14383848 ran several primary and secondary infusions that were completed and restarted during the morning.Pump module 14385616 had the most activity, including completing infusions, being turned off and back on, starting new infusions, and going through many dose changes.It also showed door open events, pump occlusion alarms, and was briefly removed and reattached before the infusions were restored.The activity continued with more secondary infusions switching back to primary until the user finally pressed key channel off.On 18 january 2026, between 12:00 am to 10:20 am, pump modules 14385357 (a), 13684574 (b), 14384151 (c), and 14383848 (d) were active as the user performed multiple restarts, handled occlusion alarms, completed an infusion, and adjusted vtbi and delays, followed by several dose changes mainly on pump module s/n14384151 and additional infusion completions.Near to 10:20 am the pump module s/n 14383848 was turned off.On 19 january 2026 from 2:15 am to 10:43 pm, pump module 14385357 (a) handled two occlusion alarms, restarted the infusion, and the user changed the dose a couple of times before turning the channel off.Pump module 13684574 (b) continued running the same secondary infusion twice, each time returning to the primary infusion before another channel off event.Pump module 14384151 (c) recorded several small dose decreases, followed by another channel off action before the user started new primary and secondary infusions.Pump module 14383848 (d) finished a primary infusion, started new primary and secondary infusions, completed another secondary to primary cycle, and ended the day with a channel off keypress.On 20 january 2026 between 12:32 am to 9:37 pm pump module 14385357 (channel a) remained attached with no infusions programmed.Pump module 13684574 (channel b) carried out all infusion activity on this date as it ran a primary infusion followed by several secondary infusions, completed each secondary and returned to primary, handled an occlusion alarm with a restart, and continued with additional secondary cycles until a channel off keypress.Pump module 14384151 (channel c) also remained active, running its own primary infusion and several secondary infusions in sequence; each secondary completed and returned to primary, including two cycles with a 50 ml vtbi and a final switch back to primary after vtbi was increased to 100 ml.Pump module 14383848 (channel d) stayed attached for the entire period with no programmed activity.The same behavior occurred on 21 january 2026 from 5:23 am to 11:13 am pump module 14385357 (channel a) and pump module 14383848 (channel d) remained attached with no programmed infusions.Pump module 13684574 (channel b) ran a primary infusion, then several secondary infusions that each completed and returned to primary, including a channel off event before programming new secondary cycles.Pump module 14384151 (channel c) also stayed active, running multiple secondary infusions, each time returning to the primary infusion.On 22 january 2026 at 10:47 am, the suspect pcu was powered on.The concomitant pump module s/n 14385357 was attached as channel a, and pump module s/n 13684574 as channel b.A log download was performed by the user.Both pump modules were disconnected at 11:26 am, and the suspect pcu was subsequently turned off.At 12:47 pm, the device was placed into maintenance mode and a log download was carried out.At 12:57 pm, the concomitant pump module s/n 14403589 was attached as channel a and the log download continued.The unit was removed at 1:16 pm.Per bd alaris system with guardrails suite mx user manual v12.3.2, the system configuration/data set is stored in compact flash memory along with operating software.The events and error logs, historical reporting logs, and the system alarm settings are stored in the on board flash memory in the pcu and modules.This is nonvolatile memory and can be held indefinitely or until replaced with new data.Logs and alarm settings are maintained even during a total loss of power to the system.The date and time of system power down is captured in the event log.The older log entries are purged as the log file reaches capacity.Module-specific parameters are stored for 8 hours when system is turned off.After 8 hours of continuous off-time, or if a module is detached, module-specific trend data (if applicable) and module-specific operating parameters are automatically purged.Per prd v12.4 the event log shall have the capacity to record at least 2000 events.Root cause: the root cause of the missing event logs from 12 january 2026 to 15 january 2026 is attributed to a log purge.The received event log revealed 9,817 recorded lines, which suggests that the user was not manually deleting logs during this period.According to the user manual, the device has 16 mb allocated for recorded logs, and once the memory reaches capacity, older log entries are automatically purged.Note that this report lists imdrf annex a1801, g02017, c0503, d08, a040502, g04037, c0601, d15 codes not associated with the reported event but identified as reportable malfunctions observed on the device during investigation are unrelated to the reported issue.These other failures presumptively did not cause or contribute to the reported issue.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
Event or Problem Description
It was reported that the customer had requested a log review of the pcu event logs.The customer would like to see the event logs dated from (b)(6).There was patient involvement but no harm.The customer had the following question/inquiry: "we would like to know why the event logs from (b)(6) 2026, are missing? only the event logs from (b)(6) are registered.".

• Brand Name: ALARIS SYSTEM
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 24812373
• Report Number: 2016493-2026-19503
• Device Sequence Number: 6146187
• Product Code: FRN
• UDI-Device Identifier: 10885403515231
• UDI-Public: (01)10885403515231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100 (6)
• Patient Sex: Unknown